FDA.reportPublic FDA data

Disposable Bulb & Bladder

Primary DI
10848956005291
Brand
Disposable Bulb & Bladder
Company
HEALTHMARK INDUSTRIES CO., INC.
Model
D30200-210
Catalog number
D30200-210
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FCYBulb, Inflation, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCYBulb, Inflation, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848956005291PrimaryGS10
00848956005294Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084895600529110848956005291
00848956005294008489560052948489560052940848956005294

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope inflation bulbA device that is used in conjunction with an endoscope and its direct application and which assists in the use of the endoscope. It is a dedicated device shaped as a rubber bulb which is used to feed air via the endoscope to obtain an endoscopic view of the site. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
057680480
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848956021263Sanizyme60030008332026-05-22
00848956021287Sanizyme60030008352026-05-22
00848956021294Sanizyme60030008362026-05-22
00848956021317Sanizyme60030008342026-05-22
10848956020010SAFEGUARD PROSGP112SGP1122025-10-20
10848956020027SAFEGUARD PROSGP115SGP1152025-10-20
10848956020034SAFEGUARD PROSGP1182025-10-20
10848956020041SAFEGUARD PROSGP124SGP1242025-10-20
10848956020058SAFEGUARD PROSGP130SGP1302025-10-20
10848956020065SAFEGUARD PROSGP136 SGP136 2025-10-20
10848956020072SAFEGUARD PROSGP212 SGP212 2025-10-20
10848956020089SAFEGUARD PROSGP218SGP2182025-10-20
10848956020096SAFEGUARD PROSGP224SGP2242025-10-20
10848956020102SAFEGUARD PROSGP230 SGP230 2025-10-20
10848956020119SAFEGUARD PROSGP236 SGP236 2025-10-20
10848956020126SAFEGUARD PROSGP324SGP3242025-10-20
10848956020133SAFEGUARD PROSGP330SGP3302025-10-20
10848956020140SAFEGUARD PROSGP336 SGP336 2025-10-20
10848956020157SAFEGUARD PROSGP345SGP3452025-10-20
10848956020164SAFEGUARD PROSGP354 SGP354 2025-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995360191NAMEDIVATORS INC.FCY2026-02-04
00724995360207NAMEDIVATORS INC.FCY2026-02-04
00724995360214NAMEDIVATORS INC.FCY2026-02-04
00724995360221NAMEDIVATORS INC.FCY2026-02-04
00724995360238NAMEDIVATORS INC.FCY2026-02-04
00724995360245NAMEDIVATORS INC.FCY2026-02-04
00816185001127Dovideq LeakControl DeviceTorvan Medical IncFCY2025-09-18
00724995244415NAMEDIVATORS INC.FCY2025-06-10
00724995244422NAMEDIVATORS INC.FCY2025-06-10
00724995244439NAMEDIVATORS INC.FCY2025-06-10
00724995244446NAMEDIVATORS INC.FCY2025-06-10
00724995244453NAMEDIVATORS INC.FCY2025-06-10
00724995244460NAMEDIVATORS INC.FCY2025-06-10
00724995244477NAMEDIVATORS INC.FCY2025-06-10
00724995244484NAMEDIVATORS INC.FCY2025-06-10
00724995244491NAMEDIVATORS INC.FCY2025-06-10
50724995244410NAMEDIVATORS INC.FCY2025-06-10
50724995244427NAMEDIVATORS INC.FCY2025-06-10
50724995244434NAMEDIVATORS INC.FCY2025-06-10
50724995244441NAMEDIVATORS INC.FCY2025-06-10
50724995244458NAMEDIVATORS INC.FCY2025-06-10
50724995244465NAMEDIVATORS INC.FCY2025-06-10
50724995244472NAMEDIVATORS INC.FCY2025-06-10
50724995244489NAMEDIVATORS INC.FCY2025-06-10
50724995244496NAMEDIVATORS INC.FCY2025-06-10
00816185001141AutoSink with Endoscope Leak TesterTorvan Medical IncFCY2025-04-28
00816185001158LT Connector 1OTorvan Medical IncFCY2025-04-28
06971919462156noneNingbo Albert Novosino Co.,Ltd.FCY2025-03-14
04048551054901n.a.Karl Storz GmbH & Co. KGFCY2024-11-29
04055207070055NARichard Wolf GmbHFCY2024-06-03